Perceived and Observed Shared Decision-Making During Anesthesia Consent for Elective Cesarean Delivery: A Cross-Sectional Study
| Registry | NCT07858084, acronym SDM-Consent |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 105 (Estimated) |
| Sponsor | University of British Columbia (Other) |
| Conditions | Shared Decision Making, Cesarean Section, Anesthesia, Obstetrical, Informed Consent |
| Interventions | Observation of anesthesia consent encounter and postpartum questionnaire (Other) |
| Dates | start 2026-10-01 (estimated), primary completion 2027-12-01 (estimated), completion 2027-12-31 (estimated), first posted 2026-10-05, last updated 2026-10-08 |
| Locations | 1 site in Canada |
Related Papers Related Patents Related Grants Related Experts
All trials for Shared Decision Making All trials for Cesarean Section All trials of Observation of anesthesia consent encounter and postpartum questionnaire
Shared decision-making (SDM) is the accepted ethical and legal standard for informed consent, but it is not known how it operates in anesthesia consent for cesarean delivery. Neuraxial anesthesia is recommended for most cesarean deliveries, and many anesthesiologists therefore present it as the only primary option, with general anesthesia (GA) available only as a rescue. Others present GA as a genuine alternative the patient can choose. This study will observe the existing variation in practice and will not change care. A trained observer will attend the pre-operative anesthesia consent encounter for women having an elective cesarean delivery at BC Women's Hospital and record which options were presented, using the observer-rated OPTION-5 instrument. Written research consent and a questionnaire follow 24-48 hours after delivery, and include the 9-item Shared Decision Making Questionnaire (SDM-Q-9). The primary aim is to compare patient-perceived SDM (SDM-Q-9) between consultations in which GA was offered as a genuine primary option and those in which it was not. This study hypothesizes that the SDM-Q-9 score will be higher when GA was offered as a primary option. Secondary aims are to describe observed SDM, decisional conflict, provider-level variation, and women's preference to be offered a choice in a future cesarean. The findings will inform a planned interventional trial of a standardized consent model.
Background. SDM, in which the clinician contributes evidence and the patient contributes values and preferences, is the ethical and increasingly the legal standard of consent (Hopp v Lepp; Reibl v Hughes; Montgomery v Lanarkshire). Major guidelines recommend neuraxial anesthesia for cesarean delivery because of the higher maternal risk of GA, and the SOAP Center of Excellence benchmark is a GA rate below 5%. Choice of technique is nevertheless preference-sensitive (being awake or asleep at the birth, partner presence, fear of needles or of awareness, prior trauma), and GA is routinely delivered when clinically required. Neuraxial block fails in about 5% of cesarean deliveries and intraoperative pain occurs in roughly 11-22%, a leading cause of maternal dissatisfaction and medicolegal action. The institutional consent discloses these risks. What varies between providers is choice: some present GA as a genuine primary option alongside neuraxial anesthesia, while others present neuraxial as the sole primary technique with GA only as rescue. A departmental poll found that 6 of 21 anesthesiologists (29%) report offering GA as a primary option. It is unknown whether offering GA as a genuine primary option affects women's perception of SDM.
Design. Single-centre, prospective, cross-sectional study at BC Women's Hospital, Vancouver. It combines (a) structured direct observation of the pre-operative anesthesia consent encounter and (b) a patient questionnaire on the 1st or 2nd postpartum day. No change is made to clinical care or to the consent process; existing variation in practice is the exposure. Because the anesthesiologist is assigned by the duty rota, women are quasi-randomly exposed to consent with or without a genuine primary choice.
Recruitment. A member of the circle of care (admitting nurse) asks the patient on the day of surgery whether they are willing to be approached. Only if they agree does a trained observer introduce the study and seek verbal assent to observation. Written informed consent is obtained 24-48 hours postpartum by a trained research assistant who is not the observer. The clinical anesthesia consent (routine care, observed) and the research consent (written, not observed) are separate processes. Providers receive an individual information sheet with an opt-out, and no per-case feedback is given. The specific exposure of interest is withheld from providers until study end; providers are not deceived about being observed.
Measures. Exposure: observer-classified offer of GA as a genuine primary option (yes/no). Observed SDM: OPTION-5, with at least 10% double-rated. Perceived SDM: SDM-Q-9 (primary outcome). Decisional conflict: Decisional Conflict Scale, descriptive. Future-choice preference. Covariates: age, parity, prior cesarean, prior anesthesia experience, education, gestational age, technique received, consultation duration.
Sample size and analysis. The primary analysis is a linear mixed-effects model with a random intercept for consenting provider, adjusted for covariates, reporting the adjusted mean difference with its 95% CI and the provider-level ICC. Assuming SD 12.4, alpha 0.05, a difference of 13.5 points, and ICC 0.10, 84 analyzable patients (4 per provider across 21 providers) give 97.7% power. Allowing about 20% attrition, the recruitment target is 105. A blinded biostatistician check of ICC, exposure split and SD after the first 105 patients will verify power; any increase in sample size will be submitted to the REB as an amendment. Reporting follows STROBE.
Data. Data are held in the institutional BCCHR/PHSA-hosted REDCap instance, keyed by study ID, with the re-identification key stored separately. Records are retained for 5 years after study completion and publication.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| GA offered as a primary option | Other: Observation of anesthesia consent encounter and postpartum questionnaire | Women whose observed pre-operative anesthesia consent presented general anesthesia as a genuine primary option the patient could choose, alongside neuraxial anesthesia. Classified per consultation by the trained observer. | |
| Neuraxial only, GA as rescue | Other: Observation of anesthesia consent encounter and postpartum questionnaire | Women whose observed pre-operative anesthesia consent presented neuraxial anesthesia as the sole primary technique, with general anesthesia available only as a rescue. |
Sex: Female, ages: 19 Years to any
Inclusion Criteria: * Age 19 years or older * Elective (scheduled) cesarean delivery at 37 weeks' gestation or later * Anesthesia consent obtained on the day of surgery * Anesthesia consent performed in English without an interpreter * Capacity to consent to research participation Exclusion Criteria: * Conversion to urgent/emergency cesarean delivery before consent is completed * Severe maternal or neonatal complication making participation inappropriate (assessed case by case with the clinical team) * Contraindication to neuraxial anesthesia * Patient declines observation pre-operatively, or declines or withdraws study consent postpartum
| Facility | City | Country | Status |
|---|---|---|---|
| BC Women's Hospital | Vancouver, British Columbia | Canada |